Bandaríkin - enska - NLM (National Library of Medicine)

bryant ranch prepack - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. solifenacin succinate is contraindicated in patients: - with urinary retention [see warnings and precautions (5.2)], - with gastric retention [see warnings and precautions (5.3)], - with uncontrolled narrow-angle glaucoma [see warnings and precautions (5.5)] , and - who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in solifenacin succinate tablets. reported adverse reactions have included anaphylaxis and angioedema [see adverse reactions (6.2)]. risk summary there are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. no adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during the period of organogenesis at a dose resulting in 1.2 times the systemic exposure at the maximum recommended human dose (mrhd) of 10 mg/day. however, administration of doses 3.6 times and greater than the mrhd during organogenesis produced maternal toxicity in the pregnant mice and resulted in developmental toxicity and reduced fetal body weights in offspring [see data]. in the u.s. general population, the estimated background risk of major birth defects or miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data oral administration of 14 c-solifenacin succinate to pregnant mice resulted in the recovery of radiolabel in the fetus indicating that solifenacin-related product can cross the placental barrier. in pregnant mice, administration of solifenacin succinate at a dose of 250 mg/kg/day (7.9 times the systemic exposure at the mrhd of 10 mg), resulted in an increased incidence of cleft palate and increased maternal lethality. administration of solifenacin succinate to pregnant mice during organogenesis at greater than or equal to 3.6 times (100 mg/kg/day and greater) the systemic exposure at the mrhd, resulted in reduced fetal body weights and reduced maternal body weight gain. no embryo-fetal toxicity or teratogenicity was observed in fetuses from pregnant mice treated with solifenacin succinate at a dose of 30 mg/kg/day (1.2 times the systemic exposure at the mrhd). administration of solifenacin succinate to pregnant rats and rabbits at a dose of 50 mg/kg/day (< 1 times and 1.8 times the systemic exposure at the mrhd, respectively), resulted in no findings of embryo-fetal toxicity. oral pre- and post-natal administration of solifenacin succinate at 100 mg/kg/day (3.6 times the systemic exposure at the mrhd) during the period of organogenesis through weaning, resulted in reduced peripartum and postnatal survival, reduced body weight gain by the pups, and delayed physical development (eye opening and vaginal patency). an increase in the percentage of male offspring was also observed in litters from offspring (f2 generation) exposed to maternal doses of 250 mg/kg/day. there were no effects on natural delivery in mice treated with 1.2 times (30 mg/kg/day) the expected systemic exposure at the mrhd. risk summary there is no information on the presence of solifenacin in human milk, the effects on the breastfed child, or the effects on milk production. solifenacin is present in mouse milk [see data]. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for solifenacin succinate and any potential adverse effects on the breastfed child from solifenacin succinate or from the underlying maternal condition. data animal data oral administration of 14 c-solifenacin succinate to lactating mice resulted in the recovery of radioactivity in maternal milk. lactating female mice orally administered solifenacin succinate at a maternally toxic dose of 100 mg/kg/day (3.6 times the systemic exposure at the mrhd) had increased postpartum pup mortality, pups with reduced body weights, or delays in the onset of reflex and physical development. pups from lactating dams orally administered solifenacin succinate at a dose of 30 mg/kg/day (1.2 times the systemic exposure at the mrhd) had no discernible adverse findings. the concentrations of solifenacin in animal milk does not necessarily predict the concentration of drug in human milk. the safety and effectiveness of solifenacin succinate tablets have not been established in pediatric patients. in placebo-controlled clinical studies, similar safety and effectiveness were observed between geriatric patients (623 patients ≥ 65 years and 189 patients ≥ 75 years) and younger adult patients (1188 patients < 65 years) treated with solifenacin succinate [see clinical pharmacology (12.3)]. solifenacin plasma concentrations are greater in patients with severe renal impairment compared to subjects with normal renal function [see clinical pharmacology (12.3)]. because increased solifenacin plasma concentrations increase the risk of antimuscarinic adverse reactions, the maximum recommended dose of solifenacin succinate in patients with severe renal impairment (cl cr < 30 ml/min/1.73 m 2 ) is 5 mg once daily [see dosage and administration (2.2)]. the recommended dose in patients with mild or moderate renal impairment is the same as in patients with normal renal function. solifenacin plasma concentrations are greater in patients with moderate hepatic impairment compared to subjects with normal hepatic function [see clinical pharmacology (12.3)]. because increased solifenacin plasma concentrations increase the risk of antimuscarinic adverse reactions, the maximum recommended dose of solifenacin succinate in patients with moderate hepatic impairment (child-pugh b) is 5 mg once daily [see dosage and administration (2.3)] and solifenacin succinate is not recommended for use in patients with severe hepatic impairment (child-pugh c). the pharmacokinetics of solifenacin is not significantly influenced by gender.

Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

psm healthcare ltd trading as api consumer brands - solifenacin succinate 10mg - film coated tablet - 10 mg - active: solifenacin succinate 10mg excipient: hypromellose lactose monohydrate magnesium stearate maize starch opadry pink 03f540032

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - solifenacin succinate, quantity: 5 mg - tablet - excipient ingredients: lactose monohydrate; maize starch; hypromellose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; macrogol 400 - solifenacin succinate is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - solifenacin succinate, quantity: 10 mg - tablet - excipient ingredients: lactose monohydrate; maize starch; hypromellose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; macrogol 8000; purified talc; iron oxide red - solifenacin succinate is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

Kanada - enska - Health Canada

jubilant generics limited - solifenacin succinate - tablet - 5mg - solifenacin succinate 5mg - antimuscarinics

Kanada - enska - Health Canada

jubilant generics limited - solifenacin succinate - tablet - 10mg - solifenacin succinate 10mg - antimuscarinics

Kanada - enska - Health Canada

pro doc limitee - solifenacin succinate - tablet - 5mg - solifenacin succinate 5mg - antimuscarinics

Kanada - enska - Health Canada

pro doc limitee - solifenacin succinate - tablet - 10mg - solifenacin succinate 10mg - antimuscarinics

Kanada - enska - Health Canada

sanis health inc - solifenacin succinate - tablet - 5mg - solifenacin succinate 5mg - antimuscarinics

Kanada - enska - Health Canada

sanis health inc - solifenacin succinate - tablet - 10mg - solifenacin succinate 10mg - antimuscarinics